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Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice

	Introduction

	Part I - Basic Requirements for Medicinal Products
Chapter 1	Pharmaceutical Quality System (2013년 1월 31일 시행)
Chapter 2	Personnel (2014년 2월 16일 시행)
Chapter 3	Premises and Equipment (2015년 3월 1일 시행)
Chapter 4	Documentation (revision January 2011)
Chapter 5	Production (2015년 3월 1일 시행)
Chapter 6	Quality Control (2014년 10월 1일 시행)
Chapter 7	Outsourced Activities (2013년 1월 31일 시행)
Chapter 8	Complaints, Quality Defects and Product Recalls (2015년 3월 1일 시행)
Chapter 9	Self Inspection

	Part II - Basic Requirements for Active Substances used as Starting Materials
	Basic Requirements for Active Substances used as Starting Materials (2014년 9월 1일 시행)

	Part III - GMP Related Documents
	Site Master File
	Q9 Quality Risk Management
	Q10 Note for Guidance on Pharmaceutical Quality System
	MRA Batch Certificate
	Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use
	Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
	Guideline of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
	Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice New

	Annexes
Annex 1	Manufacture of Sterile Medicinal Products (2022.8.22)
Annex 2	Manufacture of Biological Medicinal Products for Human Use (26 June 2018)
Annex 3	Manufacture of Radiopharmaceuticals
Annex 4	Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5	Manufacture of Immunological Venterinary Medicinal Products
Annex 6	Manufacture of Medicinal Gases
Annex 7	Manufacture of Herbal Medicinal Products
Annex 8	Sampling of Starting and Packaging Materials
Annex 9	Manufacture of Liquids, Creams and Ointments
Annex 10	Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation
Annex 11	Computerized Systems (revision January 2011)
Annex 12	Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13	Manufacture of Investigational Medicinal Products
	Detailed Commission guideline on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
Annex 14	Manufacture of Products derived from Human Blood or Human Plasma (2011년 11월 30일 시행)
Annex 15	Qualification and Validation (2015년 10월 1일 시행)
Annex 16	Certification by a Qualified person and Batch Release (2016년 4월 15일 시행)
Annex 17	Real Time Release Testing and Parametric Release (2018년 12월 26일 시행)

Annex 19	Reference Samples and Retention Samples (December 2005)

Annex 21	Importation of Medicinal Products (2022년 8월 21일 시행)

	Glossary

	Part IV - GMP Requirements for Advanced Therapy Medicinal Products
	Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

	Other documents related to GMP
	Guidelines on Good Distribution Practice of Medicinal Products for Human Use
	Gudelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use

	Guidance related to GMP/GDP and PMF distant assessments
	GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances